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A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department (MERCURY PE)

4 maggio 2018 aggiornato da: Janssen Scientific Affairs, LLC

MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department

The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants who are discharged from the Emergency Department (ED) to the home environment and treated with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or venous thromboembolism (VTE) events through Day 30 compared to participants who are treated with initial hospitalization and standard-of-care.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, multicenter (study conducted at multiple sites) study to evaluate that low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments. Safety will be monitored during the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

114

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Montgomery, Alabama, Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti
      • Phoenix, Arizona, Stati Uniti
      • Tucson, Arizona, Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti
      • Sacramento, California, Stati Uniti
      • Sylmar, California, Stati Uniti
    • Connecticut
      • New Haven, Connecticut, Stati Uniti
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti
    • Florida
      • Pensacola, Florida, Stati Uniti
      • Tampa, Florida, Stati Uniti
    • Iowa
      • Davenport, Iowa, Stati Uniti
      • Iowa City, Iowa, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti
    • Michigan
      • Detroit, Michigan, Stati Uniti
      • Jackson, Michigan, Stati Uniti
      • Lansing, Michigan, Stati Uniti
      • Royal Oak, Michigan, Stati Uniti
    • Missouri
      • Saint Louis, Missouri, Stati Uniti
    • New Jersey
      • Atlantic City, New Jersey, Stati Uniti
      • Camden, New Jersey, Stati Uniti
    • New York
      • Brooklyn, New York, Stati Uniti
      • Buffalo, New York, Stati Uniti
      • New York, New York, Stati Uniti
      • Stony Brook, New York, Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti
      • Charlotte, North Carolina, Stati Uniti
      • Durham, North Carolina, Stati Uniti
      • Winston-Salem, North Carolina, Stati Uniti
    • Ohio
      • Cincinnati, Ohio, Stati Uniti
      • Cleveland, Ohio, Stati Uniti
      • Toledo, Ohio, Stati Uniti
      • Zanesville, Ohio, Stati Uniti
    • Oregon
      • Portland, Oregon, Stati Uniti
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti
      • Bethlehem, Pennsylvania, Stati Uniti
      • Philadelphia, Pennsylvania, Stati Uniti
      • Pittsburgh, Pennsylvania, Stati Uniti
      • West Reading, Pennsylvania, Stati Uniti
    • South Carolina
      • Charleston, South Carolina, Stati Uniti
    • Texas
      • Dallas, Texas, Stati Uniti
      • Fort Worth, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
    • Utah
      • Salt Lake City, Utah, Stati Uniti
    • Virginia
      • Charlottesville, Virginia, Stati Uniti
    • Washington
      • Bellingham, Washington, Stati Uniti
      • Everett, Washington, Stati Uniti
      • Spokane, Washington, Stati Uniti
      • Tacoma, Washington, Stati Uniti

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic deep vein thrombosis (DVT)
  • A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low risk of clinical deterioration as determined by the Hestia criteria
  • Have no contraindications to and be able to complete randomized treatment and all study assessments
  • Have a life expectancy of at least 6 months
  • Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450) inhibitors (such as but not limited to ketoconazole, telithromycin or protease inhibitors) use within 4 days before randomization, or planned use during the study. Itraconazole use within 7 days before randomization or planned use during the study
  • Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned use during the study
  • Who Has contraindications to the use of any anticoagulant therapy (example, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy documented at Screening)
  • Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
  • Woman who is pregnant, or breast-feeding, or planning to become pregnant

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Rivaroxaban
Participants will receive Rivaroxaban 15 milligram (mg) orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food, for approximately 69 days for a total treatment duration of 90 days.
Droga: Rivaroxaban
Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.
Sperimentale: local Standard-of-care
Participants will receive local Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Droga: Standard-of-care
Standard-of-care as per local protocol and defined by the medical team caring for the participant.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Duration of Hospitalization
Lasso di tempo: Up to Day 30
Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.
Up to Day 30

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
Lasso di tempo: Up to 7, 14, 30, and 90 Days
Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.
Up to 7, 14, 30, and 90 Days
Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding
Lasso di tempo: Up to 7, 14, 30 and 90 Days
Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.
Up to 7, 14, 30 and 90 Days
Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
Lasso di tempo: Up to 30 and 90 Days
Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.
Up to 30 and 90 Days
Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
Lasso di tempo: Day 90
ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.
Day 90
Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
Lasso di tempo: Day 7
The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.
Day 7

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Scientific Affairs, LLC

Collaboratori

Bayer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 ottobre 2015

Completamento primario (Effettivo)

22 marzo 2017

Completamento dello studio (Effettivo)

22 marzo 2017

Date di iscrizione allo studio

Primo inviato

11 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

21 ottobre 2015

Primo Inserito (Stima)

22 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR107694
  • 39039039APE4001 (Altro identificatore: Janssen Scientific Affairs, LLC)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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